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Study of FYU-981 in Hyperuricemia With or Without Gout

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ClinicalTrials.gov Identifier: NCT02344862
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Fuji Yakuhin Co., Ltd.

Brief Summary:
The purpose of this study is exploratory investigation of safety and efficacy (dose response and optimal dose according to the percent reduction from baseline in serum urate level at the final visit) of FYU-981 administered orally to hyperuricemic patients with and without gout for 8 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 4 weeks) by the method of randomized (dynamic allocation), placebo-controlled, double-blind, parallel group comparison.

Condition or disease Intervention/treatment Phase
Hyperuricemia Drug: FYU-981 High dose, (Oral daily dosing for 8 weeks) Drug: FYU-981 Middle dose, (Oral daily dosing for 8 weeks) Drug: FYU-981 Low dose, (Oral daily dosing for 8 weeks) Drug: Placebo, (Oral daily dosing for 8 weeks) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exploratory Study of FYU-981 for Hyperuricemia With or Without Gout (Phase II (IIa) Study)
Study Start Date : January 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
Active Comparator: FYU-981 High dose Drug: FYU-981 High dose, (Oral daily dosing for 8 weeks)
Subjects randomized to the FYU-981 High dose arm receive active drug, FYU-981 High dose.

Active Comparator: FYU-981 Middle dose Drug: FYU-981 Middle dose, (Oral daily dosing for 8 weeks)
Subjects randomized to the FYU-981 Middle dose arm receive active drug, FYU-981 Middle dose.

Active Comparator: FYU-981 Low dose Drug: FYU-981 Low dose, (Oral daily dosing for 8 weeks)
Subjects randomized to the FYU-981 Low dose arm receive active drug, FYU-981 Low dose.

Placebo Comparator: Placebo Drug: Placebo, (Oral daily dosing for 8 weeks)
Subjects randomized to the placebo arm receive placebo.




Primary Outcome Measures :
  1. Percent reduction from baseline in serum urate level at the final visit [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hyperuricemic or gout patients
  • Serum urate level:

>= 7.0mg/dL in patients with history of gout, or >= 8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or >= 9.0mg/dL

Exclusion Criteria:

  • Gouty arthritis within two weeks before start of study treatment
  • Secondary hyperuricemia
  • HbA1c: >= 8.4%
  • Uric acid-overproduction type in the classification of hyperuricemia
  • History of, clinically significant cardiac, hematologic and hepatic disease
  • Kidney calculi or clinically significant urinary calculi
  • eGFR: < 60mL/min/1.73m^2
  • Systolic blood pressure: >= 180 mmHg
  • Diastolic blood pressure: >= 110 mmHg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344862


Locations
Japan
Japan
Tokyo, Japan
Sponsors and Collaborators
Fuji Yakuhin Co., Ltd.

Responsible Party: Fuji Yakuhin Co., Ltd.
ClinicalTrials.gov Identifier: NCT02344862     History of Changes
Other Study ID Numbers: FYU-981-003
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Hyperuricemia
Pathologic Processes